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Miconazole Nitrate by McKesson

Dosage form: suppository
Ingredients: MICONAZOLE NITRATE 100mg
Labeler: McKesson
NDC Code: 49348-833

Miconazole Nitrate Vaginal Suppositories

ACTIVE INGREDIENT

(in each vaginal suppository)

Miconazole nitrate 100 mg

PURPOSE

Vaginal antifungal

USE
  • treats vaginal yeast infections

WARNINGS

For vaginal use only

DO NOT USE

If you have never had a vaginal yeast infection diagnosed by a doctor

ASK A DOCTOR BEFORE USE IF YOU HAVE
  • vaginal itching and discomfort for the first time
  • vaginal yeast infections often (such as once a month or 3 in 6 months). You may have a more serious condition. You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.
  • lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.
  • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

Taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur

WHEN USING THIS PRODUCT
  • do not use tampons, douches, spermicides or other vaginal products
  • do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).
  • do not have vaginal intercourse (sex)
  • mild increase in vaginal burning, itching or irritation may occur

STOP USE AND ASK A DOCTOR IF
  • side effects occur
  • symptoms do not get better after 3 days
  • symptoms last more than 7 days
  • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

IF PREGNANT OR BREAST-FEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS
  • before using this product read the enclosed consumer information leaflet for complete instructions and information
  • adults and children 12 years of age and over: insert 1 suppository into the vagina at bedtime for 7 nights in a row.  Wash applicator after use.
  • children under 12 years:  ask a doctor

    Other Information

  • do not purchase if carton is open
  • each suppository is individually wrapped. Do not use if wrapper is missing or damaged.
  • store at room temperature 15( - 30(C (59( - 86(F), avoid heat over 30(C or 86(F.

INACTIVE INGREDIENT

Hydrogenated vegetable oil

QUESTIONS?

1-800-432-8534 (select option #2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark

COMPARE TO MONISTAT® 7 ACTIVE INGREDIENT*

NDC 49348-833-61

Miconazole 7

Vaginal Suppositories

Miconazole Nitrate Vaginal Suppositories USP, 100 mg

Vaginal Antifungal

Cures most vaginal yeast infections

7 VAGINAL SUPPOSITORIES WITH APPLICATOR

1 REUSABLE APPLICATOR CARTON LABEL

EDUCATIONAL BROCHURE

Miconazole Nitrate Vaginal Suppositories USP, 100 mg

Vaginal Antifungal

Cures Most Vaginal Yeast Infections

INDICATION

For the treatment of vaginal yeast infections (candidiasis).

If you have any or all the symptoms of a yeast infection (vaginal itching, burning, discharge) and if at some time in the past your doctor has told you that these symptoms are due to a yeast infection, then Miconazole Nitrate Vaginal Suppositories should work for you. If, however, you have never had these symptoms before, you should see your doctor before using this product. MICONAZOLE NITRATE VAGINAL SUPPOSITORIES ARE FOR THE TREATMENT OF VAGINAL YEAST INFECTIONS ONLY. THEY DO NOT TREAT OTHER INFECTIONS AND DO NOT PREVENT PREGNANCY.

WHAT ARE VAGINAL YEAST INFECTIONS (CANDIDIASIS)?

A yeast infection is a common type of vaginal infection. Your doctor may call it candidiasis. This condition is caused by an organism called Candida, which is a type of yeast. Even healthy women usually have this yeast on the skin, in the mouth, in the digestive tract, and in the vagina. At times, the yeast can grow very quickly. In fact, the infection is called yeast (Candida) “overgrowth”.

A yeast infection can occur at almost any time of life. It is most common during the childbearing years. The infection tends to develop most often in some women who are pregnant, diabetic, taking antibiotics, birth control pills, or have a damaged immune system.

Various medical conditions can damage the body’s normal defenses against infection. One of the most serious of these conditions is infection with the human immunodeficiency virus (HIV – the virus that causes AIDS). Infection with HIV causes the body to be more susceptible to infections, including vaginal yeast infections. Women with HIV infection may have frequent vaginal yeast infections or, especially, vaginal yeast infections that do not clear up easily with proper treatment. If you may have been exposed to HIV and are experiencing either frequently recurring vaginal yeast infections, or especially, vaginal yeast infections that do not clear up easily with proper treatment, you should see your doctor promptly. If you wish further information on risk factors for HIV infection, or on the relationship between recurrent or persistent vaginal yeast infections and HIV infection, please contact your doctor or the CDC National AIDS HOTLINE at 1-800-342-AIDS (English), 1-800-344-7432 (Spanish), or 1-800-243-7889 (Hearing Impaired, TDD).

IF YOU EXPERIENCE VAGINAL YEAST INFECTIONS FREQUENTLY (THEY RECUR WITHIN A TWO MONTH PERIOD) OR IF YOU HAVE VAGINAL YEAST INFECTIONS THAT DO NOT CLEAR UP EASILY WITH PROPER TREATMENT, YOU SHOULD SEE YOUR DOCTOR PROMPTLY TO DETERMINE THE CAUSE AND TO RECEIVE PROPER MEDICAL CARE.

SYMPTOMS OF VAGINAL YEAST INFECTIONS

There are many signs and symptoms of a yeast infection. They can include:

  • Vaginal itching (ranging from mild to intense);
  • A clumpy, white vaginal discharge that may look like cottage cheese;
  • Vaginal soreness, irritation or burning, especially during intercourse.
  • Rash or redness around the vagina.

Note: Vaginal discharge that is different from above, for example, a yellow/green discharge or a discharge that smells “fishy”, may indicate that you have something other than a yeast infection. If this is the case, you should consult your doctor before using Miconazole Nitrate Vaginal Suppositories.

Warnings

  • This product is only effective in treating vaginal infection caused by yeast. Do not use in eyes or take by mouth.
  • Do not use Miconazole Nitrate Vaginal Suppositories if you have any of the following signs and symptoms. Also, if they occur while using Miconazole Nitrate Vaginal Suppositories, STOP using the product and contact your doctor right away. You may have a more serious illness.

    Fever (above 100°F orally)

    Pain in the lower abdomen, back or either shoulder

    A vaginal discharge that smells bad

  • Ask a doctor or pharmacist before use if you are taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur.
  • If there is no improvement or the infection worsens within 3 days, or complete relief is not felt within 7 days, or your symptoms return within two months, then you may have something other than a yeast infection. You should consult your doctor.
  • talking to your doctor first.
  • If your doctor has previously told you that you are sensitive or allergic to any miconazole nitrate product, do not use Miconazole Nitrate Vaginal Suppositories without talking to your doctor first.
  • Do not use tampons while using this medication.
  • Do not use in girls less than 12 years of age.
  • If you are pregnant or think you may be, do not use this product except under the advice and supervision of a doctor.
  • Keep this and all drugs out of the reach of children.
  • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

CONTENTS

Seven vaginal suppositories each containing 100 mg miconazole nitrate. One plastic applicator.

IMPORTANT: EACH SUPPOSITORY IS INDIVIDUALLY WRAPPED. IF WRAPPER IS MISSING OR DAMAGED, DO NOT USE. RETURN THE PRODUCT TO THE STORE WHERE YOU BOUGHT IT

DIRECTIONS FOR USE

To begin treatment, wait until bedtime. Before going to bed:

  1. Tear off one suppository from the strip. Separate the plastic wrap at the pointed end with your thumb. With thumb and forefinger of each hand, hold the plastic tabs and pull apart (see picture). Gently remove the suppository from the plastic wrap.
  2. Place suppository in the top of the applicator as shown.
  3. Hold the applicator containing the suppository by the opposite end from where the suppository is. Gently insert the applicator into the vagina as far as it will comfortably go. As shown in the pictures, this can be done while standing with your feet spread a few inches apart and your knees bent. Or, you can lie on your back with your knees bent. Once you are ready, push the inside piece of the applicator in and place the suppository as far back in the vagina as possible. Then remove the applicator from the vagina. You should go to bed as soon as possible after inserting the suppository. This will keep leakage to a minimum.

    You may want to use deodorant-free mini-pads or pantyshields during the time that you are using Miconazole Nitrate Vaginal Suppositories. This is because the suppository can leak and/or you may see some discharge. DO NOT USE TAMPONS.

  4. Be sure to clean the applicator after each use. Pull the two pieces apart. Wash them with soap and warm water. To rejoin, gently push the inside piece into the outside piece as far as it will go.
  5. Repeat steps 1 through 4 before going to bed on each of the next six evenings.

ADVERSE REACTIONS (SIDE EFFECTS)

The following side effects have been reported with the use of Miconazole Nitrate Vaginal Suppositories: a temporary increase in burning, itching, and/or irritation when the suppository is inserted. Abdominal cramping, headaches, hives, and skin rash have also been reported. If any of these occur, stop using the product and consult your doctor.

FOR BEST RESULTS

  1. Be sure to use all of the suppositories even if your symptoms go away before you have used all the suppositories.
  2. Use one suppository at bedtime for seven nights in a row, even during your menstrual period.
  3. Wear cotton underwear.
  4. If your partner has any penile itching, redness, or discomfort, he should consult his doctor and mention that you are treating a yeast infection.
  5. Dry the outside vaginal area thoroughly after a shower, bath or swim. Change out of a wet bathing suit or damp workout clothes as soon as possible. A dry area is less likely to encourage the growth of yeast.
  6. Wipe from front to rear (away from the vagina) after a bowel movement.
  7. Don’t douche unless your doctor tells you to do so. Douching may disturb the vaginal bacteria balance.
  8. Do not scratch if you can help it. Scratching can cause more irritation and can spread the infection.
  9. Discuss with your doctor any medication you are now taking. Certain types of medication can make your vagina more prone to infection.

IF YOU HAVE A QUESTION

Questions of a medical nature should be taken up with your doctor.

ACTIVE INGREDIENT

Miconazole nitrate (100 mg each suppository).

STORAGE

Store at room temperature 59°-86°F (15°-30°C). Avoid heat (over 86°F or 30°C).

See end flap for lot number and expiration date.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Manufactured by:

Actavis Mid Atlantic LLC

1877 Kawai Road,

Lincolnton NC 28092 USA

FORM NO. 1736

Rev. 8/08

VC3337

MICONAZOLE NITRATE 
miconazole nitrate suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-833
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE100 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM KERNEL OIL 
Packaging
#Item CodePackage Description
1NDC:49348-833-617 SUPPOSITORY (SUPPOSITORY) in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07350712/09/2011
Labeler - McKesson (177667227)
Registrant - Actavis Mid Atlantic LLC (809515898)
Establishment
NameAddressID/FEIOperations
Actavis Mid Atlantic LLC809515898MANUFACTURE

Revised: 12/2011
 
McKesson

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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